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Antihistamine

Loratadine for Back and Leg Pain

Phase 2
Waitlist Available
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week after pegfilgrastim
Awards & highlights

Study Summary

The purpose of this study is to determine the incidence of pegfilgrastim-induced back and leg pain and to determine whether the antihistamine loratadine can prevent pegfilgrastim-induced back and leg pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week after pegfilgrastim
This trial's timeline: 3 weeks for screening, Varies for treatment, and one week after pegfilgrastim for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine
Secondary outcome measures
Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain
Incidence of pegfilgrastim-induced back and leg pain

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: LoratadineActive Control1 Intervention
Loratadine 10 mg once a day for 7 days beginning the day of pegfilgrastim treatment in patients with pegfilgrastim-induced back and leg pain during the previous treatment cycle
Group II: PlaceboPlacebo Group1 Intervention
Placebo once a day for 7 days beginning the day of pegfilgrastim treatment in patients with pegfilgrastim-induced back and leg pain during the previous treatment cycle

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
267 Previous Clinical Trials
3,743,686 Total Patients Enrolled
Cancer and Leukemia Group BNETWORK
80 Previous Clinical Trials
117,933 Total Patients Enrolled
Steven M Grunberg, MDStudy ChairUniversity of Vermont
1 Previous Clinical Trials
37 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain
Steven Grunberg 2011. "Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01311336.
All > Prevention
~4 spots leftby Apr 2025
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